Sofosbuvir and Velpatasvir Tablets Recalled for Defective Blister Pack Sealing
Asegua Therapeutics is recalling 18,541 cartons of Sofosbuvir and Velpatasvir tablets nationwide due to defective blister packs that are not properly sealed, resulting in loose tablets in cartons. No illnesses or injuries have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is FDA Class II with no reported illnesses or injuries. The hazard—improperly sealed blister packs causing loose tablets—is a packaging defect rather than a product defect, consistent with voluntary precautionary recalls.
Plain-English summary
Asegua Therapeutics LLC is recalling 18,541 cartons of Sofosbuvir and Velpatasvir combination tablets (400mg/100mg) due to defective packaging. Blister packs in the affected cartons are not properly sealed, allowing tablets to become loose.
The affected product is sold under the brand name Sofosbuvir and Velpatasvir, manufactured for Asegua Therapeutics LLC, an affiliate of Gilead Sciences. The affected lot is 24ASV002UA with an expiration date of 6/30/2028. The product NDC is 72626-2701-1. The recall covers nationwide distribution in the United States.
Sofosbuvir and Velpatasvir is an oral antiviral combination used to treat chronic hepatitis C. The unsealed blister packs could allow tablets to be exposed to environmental conditions during storage and transportation. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- SOFOSBUVIR AND VELPATASVIR (VELPATASVIR AND SOFOSBUVIR)
- Brand
- SOFOSBUVIR AND VELPATASVIR
- Manufacturer
- ASEGUA THERAPEUTICS LLC
- Category
- Drug — Antiviral / Hepatitis C
- Affected units
- 18,541
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 24ASV002UA
- Exp Date: 6/30/2028
Distribution
Distributed nationwide across the United States.
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